[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578202":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":34,"centralContacts":38,"locations":43,"responsibleParty":60,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":30,"enrollmentInfo":77,"targetDuration":30,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":45,"whyStopped":30,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Brigham and Women's Hospital","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","Participants assigned to this arm will take four placebo pills per day.",[13],"Dietary Supplement: Cocoa extract placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"500 mg cocoa extract","EXPERIMENTAL","Participants assigned to this arm will take two 250 mg cocoa extract pills per day and two placebo pills per day",[19],"Dietary Supplement: Cocoa extract",{"label":21,"type":16,"description":22,"interventionNames":23},"1000 mg cocoa extract","Participants assigned to this arm will take four 250 mg cocoa extract pills per day",[19],[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DIETARY_SUPPLEMENT","Cocoa extract","Cocoa extract manufactured as 250 mg capsules",[21,15],null,{"type":26,"name":32,"description":32,"armGroupLabels":33,"otherNames":30},"Cocoa extract placebo",[9],[35],{"name":36,"affiliation":5,"role":37},"Pamela M Rist, ScD","PRINCIPAL_INVESTIGATOR",[39],{"name":36,"role":40,"phone":41,"phoneExt":30,"email":42},"CONTACT","877-517-2555","bwhcoral@mgb.org",[44],{"facility":5,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Boston","Massachusetts","02115","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-71.05977,42.35843,{"lat":55,"lon":54},[58],{"name":36,"role":40,"phone":30,"phoneExt":59,"email":42},"(877) 517-2555",{"type":37,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Pamela M. Rist, ScD","Associate Epidemiologist",[64],{"name":65,"class":66},"National Center for Complementary and Integrative Health (NCCIH)","NIH","100578202","cocoa-extract-for-migraine-trial-100578202",false,"NCT06808230","Cocoa Extract for Migraine Trial","Cocoa Flavanols for Migraine: A Pilot Study","CORAL","Inclusion Criteria:\n\n* Women and men aged ≥18 years\n* Self-reported clinician diagnosis of migraine with or without aura which does not meet criteria for chronic migraine (according to the International Classification of Headache Disorders 3rd edition)\n\n  * Individuals with self-reported migraine will need to report a clinician diagnosis of migraine and be classified as having migraine or probable migraine by the American Migraine Study (AMS) migraine screener. The AMS migraine screener, which has a sensitivity of 100% and a specificity of 82% for the diagnosis of migraine will be used to confirm self-reported migraine status.\n  * History of migraine dating for at least one year\n* Self-report of 4 to 14 migraine attacks during the 30 days prior to enrollment in the study\n* Completion of at least 22 headache diary days during the 28 day run-in period\n\n  o Report migraine frequency between 4 to 14 days during the 28 day run-in period\n* If currently using medications to prevent or treat migraine, no new medication use within the past 3 months\n* No new use of behavioral interventions within the past 3 months and\u002For agree to not begin new behavioral interventions during this trial\n* Be willing to complete all study procedures and be randomized to all interventional groups\n* Be fluent in English\n* Own an iPhone or Android device and be willing to download MyCap to the device\n\nExclusion Criteria:\n\n* Self-reported history of stroke or transient ischemic attack; history of brain surgery or spine surgery; currently receiving treatment for a concussion; and self-reported diagnosis of cluster headache, brain tumor, brain aneurysm, traumatic brain injury, multiple sclerosis, epilepsy, schizophrenia, or bipolar disorder\n* Kidney failure or current dialysis treatment or any medical condition which the participant believes could lead to difficulty complying with the protocol\n* Current alcohol or substance abuse (self-reported)\n* Self-reported clinician diagnosis of medication overuse headache\n* Currently or recently (past 6 months) received Botox treatment for migraine\n* Failure to return the baseline urine sample\n* Currently pregnant, nursing, or intending to become pregnant during the study period.\n* Unwilling to forgo use of out-of-study supplements of cocoa extract during the trial\n* Extreme sensitivity to caffeine","ALL","18 Years",{"count":78,"type":79},114,"ESTIMATED","INTERVENTIONAL",[82],"NA","The goal of this clinical trial is to assess the feasibility of recruitment and adherence to a high-dose cocoa extract supplement in individuals diagnosed with episodic migraine. The main questions it aims to answer are:\n\n* Will we be able to enroll 114 participants during the recruitment period?\n* Will participants take study pills daily during the pill-taking period?\n\nResearchers will compare two doses of cocoa extract to placebo to determine the acceptability of higher doses of cocoa extract supplementation in this patient population.\n\nParticipants will be asked to:\n\n* Provide two urine samples\n* Complete daily questionnaires\n* Take four study pills a day for 12 weeks",[85],"Migraine",[87,88,89],"migraine","cocoa extract","cocoa flavanol","2026-06-25",{"date":92,"type":93},"2026-06-29","ACTUAL",{"date":95,"type":93},"2025-06-23",{"date":97,"type":79},"2026-12-01",{"name":5,"class":6},1]